Phase 1/2 Study of BDTX-1535 in Patients with Glioblastoma or Non-Small Cell Lung Cancer with EGFR Mutations
Sponsor: Black Diamond Therapeutics, Inc.
ClinicalTrials ID:NCT05256290
The BDTX-1535-101 trial assesses BDTX-1535, a 4th generation EGFR inhibitor, in adults with advanced NSCLC or glioblastoma. Phase 1 is complete; Phase 2 is enrolling. Participants self-administer the drug orally in 21-day cycles. Eligibility includes EGFR mutations in NSCLC or EGFR alterations in glioblastoma. The study evaluates safety, PK, CNS, and antitumor activity.
Patient Parameters
| Parameter | Options |
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Program Overview
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer BDTX-1535 monotherapy by mouth in 21-day cycles.
Phase 1 enrollment is now complete. Phase 2 is currently enrolling.
Eligibility Criteria
Exclusion Criteria
- Known resistant mutations in tumor tissue or by liquid biopsy (eg, T790M, MET).
- Received more than 1 EGFR TKI therapy (ie, erlotinib or gefitinib) for the treatment of metastatic or recurrent EGFR NSCLC.
- Any history of interstitial lung disease related to EGFR TKI use.
- Symptomatic or radiographic leptomeningeal disease.
- Symptomatic brain metastases or spinal cord compression requiring urgent clinical intervention.
- Unresolved toxicity from prior therapy.
- Significant cardiovascular disease.
- Major surgery within 4 weeks of study entry or planned during study.
- Ongoing or recent anticancer therapy or radiation therapy.
- Evidence of malignancy (other than study-specific malignancies) requiring active therapy within the next 2 years.
- Active hepatitis B or C infection and/or known human immunodeficiency virus (HIV) carrier.
- Poorly controlled gastrointestinal disorders.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama | 35294 | Birmingham | Alabama |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| City of Hope Comprehensive Cancer Center (Duarte Campus) | 91010 | Duarte | California |
| City of Hope Huntington Beach | 92648 | Huntington Beach | California |
| City of Hope Orange County Lennar Foundation Cancer Center | 92618 | Irvine | California |
| City of Hope- Long Beach | 90813 | Long Beach | California |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| Valkyrie Clinical Trials | 90067 | Los Angeles | California |
| Johns Hopkins Bayview Medical Center | 20016 | Washington | District of Columbia |
| Sibley Memorial Hospital Johns Hopkins Medicine | 20016 | Washington | District of Columbia |
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